Warning

For all patients taking this medicine:

This medicine has an opioid drug in it. Opioid drugs can put you at risk for addiction, abuse, and misuse. Misuse or abuse of Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension) can
lead to overdose and death. If you have questions, talk with your doctor.

This medicine has an opioid drug in it. The use of opioid drugs along with a benzodiazepine drug or other drugs that may make you drowsy or
slow your actions has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and deaths.
Benzodiazepine drugs include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepine drugs are used to treat many health problems like
anxiety, trouble sleeping, or seizures. Talk with the doctor.

Many drugs interact with Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension) and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and
pharmacist to make sure it is safe to use Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension) with all of your drugs.

Avoid alcohol or other drugs and natural products that slow your actions.

Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right
away if the patient does not respond, does not answer or react like normal, or will not wake up.

Very bad and sometimes deadly breathing problems have happened with Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension). Talk with the doctor.

Get medical help right away if you have slow breathing, shallow breathing, or trouble breathing.

Children:

Do not give Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension) to a child younger than 18 years of age for signs of a cold or other infection. The benefits of taking Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension) do
not outweigh the risks in children. If your child has been given Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension) or if you have any questions, talk with your child's doctor.

Uses of Zodryl DAC:

What do I need to tell my doctor BEFORE I take Zodryl DAC?

If you have an allergy to chlorpheniramine, pseudoephedrine, codeine, or any other part of Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension).

If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what
signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon
dioxide in the blood; or stomach or bowel block or narrowing.

If you are breast-feeding. Do not breast-feed while you take Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension).

This is not a list of all drugs or health problems that interact with Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check
to make sure that it is safe for you to take Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension) with all of your drugs and health problems. Do not start, stop, or change the dose of
any drug without checking with your doctor.

What are some things I need to know or do while I take Zodryl DAC?

Tell all of your health care providers that you take Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension). This includes your doctors, nurses, pharmacists, and dentists.

Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.

Do not take Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension) for longer than you were told by your doctor.

This medicine may be habit-forming with long-term use.

Avoid driving and doing other tasks or actions that call for you to be alert until you see how Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension) affects you.

To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down
stairs.

Do not take Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension) with other strong pain drugs or if you are using a pain patch without talking to your doctor first.

This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension).

The chance of very bad side effects may be higher in children. This may be more likely to happen in children who have breathing problems.
Deadly breathing problems have happened with the use of codeine in some children. Talk with the doctor.

If you are 65 or older, use Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension) with care. You could have more side effects.

This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking
Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension), call your doctor right away.

Using Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension) for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the
doctor.

How is this medicine (Zodryl DAC) best taken?

Use Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Take with or without food. Take with food if it causes an upset stomach.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your
doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing;
tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue,
or throat.

What are some other side effects of Zodryl DAC?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical
help if any of these side effects or any other side effects bother you or do not go away:

Dizziness.

Feeling nervous and excitable.

Not able to sleep.

Feeling sleepy.

Hard stools (constipation).

Upset stomach or throwing up.

Sweating a lot.

Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical
advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was
taken, how much, and when it happened.

How do I store and/or throw out Zodryl DAC?

Store at room temperature.

Protect from light.

Store in a dry place. Do not store in a bathroom.

Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.

Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your
pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

If your symptoms or health problems do not get better or if they become worse, call your doctor.

Do not share your drugs with others and do not take anyone else's drugs.

Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.

Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.

Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension), please talk
with your doctor, nurse, pharmacist, or other health care provider.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was
taken, how much, and when it happened.

Disclaimer:
This information should not be used to decide whether or not to take Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension) or any other medicine. Only the healthcare provider has the
knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe,
effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension).
It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that
may apply to Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension). This information is not specific medical advice and does not replace information you receive from the healthcare
provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Zodryl DAC (chlorpheniramine, pseudoephedrine, and codeine suspension).